Home NDC 50580-451 TYLENOL
Product NDC 50580-451
11-digit product format 505800451
Labeler code 50580
Product ID 50580-451_2d87c8e1-e743-56cc-e063-6394a90aac79
Type HUMAN OTC DRUG
Nonproprietary name Acetaminophen
Dosage form TABLET, COATED
Route ORAL
Labeler Kenvue Brands LLC
Application M013
Marketing category OTC MONOGRAPH DRUG
Marketing start 1994-08-19
Substance ACETAMINOPHEN
Active strength 500 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Observed NDC auxiliary status history# This history shows the information present in each captured FDA auxiliary file. It is not a continuous regulatory timeline, and a missing record does not establish a status.
Historic NDC status page 1 of 1 · 24 matching rows.
View current auxiliary records. · View the auxiliary file history.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base TYLENOL
Brand name suffix Extra Strength
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength ACETAMINOPHEN 500 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 362O9ITL9D Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 2 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 198440 Internal RxNorm lookup 209459 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 50580-451-03 TYLENOLExtra Strength 1 in 1 POUCH TABLET, COATED 1 16 50580-451-03 TYLENOLExtra Strength 150 in 1 CARTON TABLET, COATED 150 16 50580-451-10 TYLENOLExtra Strength 10 in 1 CARTON TABLET, COATED 10 16 50580-451-10 TYLENOLExtra Strength 10 in 1 BLISTER PACK TABLET, COATED 10 16 50580-451-50 TYLENOLExtra Strength 1 in 1 CARTON TABLET, COATED 1 16 50580-451-50 TYLENOLExtra Strength 50 in 1 BOTTLE, PLASTIC TABLET, COATED 50 16 50580-451-70 TYLENOLExtra Strength 700 in 1 BOTTLE, PLASTIC TABLET, COATED 700 16
DailyMed Socrata Ingredients# Ingredient, Type, UNII table Ingredient Type UNII DailyMed label SPL version Uploaded Acetaminophen ACTIVE INGREDIENT 362O9ITL9D TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Acetaminophen ACTIVE MOIETY 362O9ITL9D TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 aluminum oxide INACTIVE INGREDIENT LMI26O6933 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Carnauba wax INACTIVE INGREDIENT R12CBM0EIZ TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 castor oil INACTIVE INGREDIENT D5340Y2I9G TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 FD&C red No. 40 INACTIVE INGREDIENT WZB9127XOA TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 hypromelloses INACTIVE INGREDIENT 3NXW29V3WO TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 magnesium stearate INACTIVE INGREDIENT 70097M6I30 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Polyethylene glycols INACTIVE INGREDIENT 3WJQ0SDW1A TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 powdered cellulose INACTIVE INGREDIENT SMD1X3XO9M TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 propylene glycol INACTIVE INGREDIENT 6DC9Q167V3 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 shellac INACTIVE INGREDIENT 46N107B71O TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 Sodium Starch Glycolate Type A Potato INACTIVE INGREDIENT 5856J3G2A2 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 starch, corn INACTIVE INGREDIENT O8232NY3SJ TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5 titanium dioxide INACTIVE INGREDIENT 15FIX9V2JP TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [JOHNSON & JOHNSON CONSUMER INC., MCNEIL CONSUMER HEALTHCARE DIVISION] 5
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 50580-451 TYLENOL EXTRA STRENGTH (ACETAMINOPHEN) TABLET, COATED [KENVUE BRANDS LLC] 16 Current NDC, Legacy NDC, 7 package rows 20250221_bb6533e5-e6a9-488c-b8ab-a6a06e87ede9.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 23 of 79 · 1,579 matching rows.
Brand, Generic, Manufacturer table Brand Generic Manufacturer SPL set ID Effective date Available safety fields Join Aspirin 81 mg ASPIRIN HYVEE INC 3e602287-565e-a5b9-e063-6294a90abc17 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN DELAYED RELEASE 81MG ASPIRIN DELAYED RELEASE 81MG Farmacias De Similares TX LLC 3a8a3efc-f0b3-411c-e063-6394a90a84b7 2026-01-13 Warnings Exact identifier application number: M013 Chewable Aspirin 81 mg ASPIRIN HYVEE INC 459f749f-9d23-8752-e063-6394a90a8c81 2026-01-13 Warnings Exact identifier application number: M013 ASPIRIN 325 mg ASPIRIN HYVEE INC 459d01df-6ff6-cff6-e063-6394a90ab35c 2026-01-13 Warnings Exact identifier application number: M013 Pain Terminator Extra Strength Pain Relief CAFFEINE, ACETAMINOPHEN, ASPIRIN Wildman Business Group 8ffb02d9-92df-4d2f-a367-1c71490807fb 2026-01-12 Warnings Exact identifier application number: M013 Aspirin Packs ASPIRIN Sina Health Inc 2865a2c3-53fc-ab9a-e063-6394a90a1418 2026-01-12 Warnings Exact identifier application number: M013 Acetaminophen ACETAMINOPHEN PD-Rx Pharmaceuticals, Inc. 64696f65-415e-4ce1-a5b3-70662fbcb002 2026-01-12 Warnings Exact identifier application number: M013 Aspirin enteric coated low dose ASPIRIN Walgreen Company 186a6270-e3de-4499-88a4-5f723fee3e34 2026-01-12 Warnings Exact identifier application number: M013 Tension Headache ACETAMINOPHEN, CAFFEINE Cardinal Health 110, LLC. DBA Leader 96684e3f-a13e-49c3-b437-d2627e528a2d 2026-01-12 Warnings Exact identifier application number: M013 Low Dose Aspirin ASPIRIN Family Dollar Services Inc d35d798e-76f1-454d-86f6-ad11c3bf17d8 2026-01-12 Warnings Exact identifier application number: M013 Xpect Acetaminophen ACETAMINOPHEN Cintas Corporation f4aed854-730e-493d-b523-122156e08dde 2026-01-09 Warnings Exact identifier application number: M013 Aspirin ASPIRIN INVAHEALTH INC e5e8a8d5-9174-7975-e053-2a95a90a9aa6 2026-01-08 Warnings Exact identifier application number: M013 Xpect Cold Relief ACETAMINOPHEN GUAIFENESEIN PHENYLEPHRINE HCL Cintas Corporation 02391d55-32b2-4083-9315-98e9b3650c55 2026-01-08 Warnings Exact identifier application number: M013 pain relief back and body EXTRA STRENGTH ASPIRIN, CAFFEINE Rite Aid Corporation a71392c8-3f5b-4d00-baba-a4055ed68bc1 2026-01-07 Warnings Exact identifier application number: M013 Pain Reliever Extra Strength ACETAMINOPHEN L.N.K. International, Inc. 8fed703a-9de2-4c76-a783-fcf004f9b890 2026-01-07 Warnings Exact identifier application number: M013 Aspirin ASPIRIN Amerisource Bergen c3099892-a8cd-4574-a6f9-041e59e2feae 2026-01-07 Warnings Exact identifier application number: M013 Bactimicina Childrens Pain and Fever ACETAMINOPHEN DLC Laboratories, Inc. bdade270-d813-4178-b594-4951632b6839 2026-01-07 Warnings Exact identifier application number: M013 Goodmeds Extra Strength Pain Relief PM ACETAMINOPHEN, DIPHENHYDRAMINE HYDROCHLORIDE Cabinet Health P.B.C. 02c60967-46d7-49b7-82be-bc3c5fd36484 2026-01-06 Warnings Exact identifier application number: M013 Childrens Acetaminophen ACETAMINOPHEN ARMY AND AIR FORCE EXCHANGE SERVICE a73f8217-9eae-4e2a-b29c-7de3861d0e37 2026-01-06 Warnings Exact identifier application number: M013 Pain Relief Acetaminophen PM ACETAMINOPHEN AND DIPHENHYDRAMINE HCL Rite Aid Corporation f77f0120-4042-4b11-ba9c-cd35e1cd0bee 2026-01-05 Warnings Exact identifier application number: M013
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Marketing start Marketing end Sample Exclude flag Status 50580-451-03 50580045103 1 in 1 POUCH Historical 50580-451-10 50580045110 10 in 1 CARTON Historical 50580-451-50 50580045150 1 BOTTLE, PLASTIC in 1 CARTON (50580-451-50) / 50 TABLET, COATED in 1 BOTTLE, PLASTIC 1994-08-19 0000-00-00 No No Current 50580-451-70 50580045170 700 TABLET, COATED in 1 BOTTLE, PLASTIC (50580-451-70) 1994-08-19 0000-00-00 No No Current